Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

NCT04079101 | Completed Phase 1 FDA Drug

• 1 other identifier: 263HV106
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (11)

• Maximum Observed Concentration of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Time to Reach Maximum Observed Concentration of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Maximum Observed Concentration at Steady State of BIIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Time to Reach Maximum Observed Concentration at Steady State of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Apparent Total Body Clearance of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Apparent Volume of Distribution of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Elimination Half-Life of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Accumulation Ratio at Steady State of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

• Trough Concentration of BIIB104

  pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11

Secondary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  Baseline (Day 1) up to Day 14

• Number of Participants With Serious Adverse Events (SAEs)

  Screening up to Day 14

Study Arms (3)

BIIB104 0.15 mg

EXPERIMENTAL

Participants will receive multiple oral doses of BIIB104 0.15 mg capsules twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10.

Drug: BIIB104

BIIB104 0.5 mg

EXPERIMENTAL

Participants will receive multiple oral doses of BIIB104 0.5 mg capsules BID for 9 days, with an additional dose occurring in the morning on Day 10.

Drug: BIIB104

Placebo

EXPERIMENTAL

Participants will receive multiple oral doses of placebo-matched BIIB104 capsules BID for 9 days, with an additional dose occurring in the morning on Day 10.

Drug: Placebo

Interventions

BIIB104 DRUG

Administered as specified in the treatment arm.

Also known as: PF-04958242

BIIB104 0.15 mg; BIIB104 0.5 mg

Placebo DRUG

Administered as specified in the treatment arm.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For Japanese participants, was born in Japan, and biological parents and grandparents were of Japanese origin.
• For Japanese participants, if living outside Japan for more than 5 years, must not have significantly modified diet since leaving Japan.
• Non-Japanese participants must have a screening weight within ±20% of the mean value for Japanese participants.

You may not qualify if:

• Suicide attempt within the last 2 years. Participants who, in the Investigator's judgment, pose a significant suicide risk or who have suicidal ideation associated with actual intent and a method or plan in the past 6 months (i.e., "Yes" answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale) will be excluded from the study.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Long Beach, California, 90806, United States

Location

MeSH Terms

Interventions

PF-04958242

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 2, 2019
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)